DeviceClearance

Novii+ Wireless Patch System— 510(k) K254036

Substantially Equivalent

Datex Ohmeda, Inc.

FDA 510(k) clearance K254036 for Novii+ Wireless Patch System, Substantially Equivalent on 2026-08-10. Applicant: Datex Ohmeda, Inc.. Device class: 2.

Summary

Datex Ohmeda's Novii+ Wireless Patch System is filed under product code HGM, perinatal monitoring systems. The record gives no model numbers.

Class II, 21 CFR 884.2740. Obstetrics/Gynecology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Datex Ohmeda filed from Waukesha, Wisconsin. The decision came 237 calendar days after receipt (December 16, 2025 to August 10, 2026), and it was substantially equivalent.

Clearance details

Applicant
Datex Ohmeda, Inc.
Product code
Product code HGM
Device class
Class 2
Regulation
21 CFR 884.2740
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HGM

product code HGM
Death
35
Malfunction
478
Total
513

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.